New Product Addresses Short to Mid-Gap Nerve Repair

Princeton, New Jersey-based Integra LifeSciences Holding Corporation has launched the NeuraGen 3D Nerve Guide Matrix, a resorbable implant which addresses short to mid-gap peripheral nerve discontinuities.

Simon Archibald, Ph.D., VP and chief scientist of Integra LifeSciences explained the new product, which is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, to OTW, “Peripheral nerve injury is a major clinical problem and is estimated to affect more than five million people worldwide every year. NeuraGen 3D Nerve Guide Matrix is the first innovation in several years in the peripheral nerve repair industry, particularly in the conduit space. It is a significant advancement in the field and is Integra’s most advanced and complex matrix product created to date.”

“NeuraGen 3D is a combination of an outer conduit made of Integra’s trusted bovine type 1 collagen and a unique inner matrix with longitudinally aligned porous channels.”

“In preclinical studies, the inner matrix has been demonstrated to help guide Schwann cell migration and direct axonal growth, which are both important objectives for surgeons in the successful treatment of nerve injuries and subsequent restoration of function.”

“With the introduction of this product, surgeons have a new short to mid-gap nerve repair solution designed to provide an optimized healing environment for nerve repair, which may lead to more meaningful patient outcomes.”

“I am very excited about the launch of NeuraGen 3D,” said Suhail Mithani, M.D., associate professor of Orthopedic and Plastic Surgery at Duke University, Division of Hand Surgery. “It’s the first product that has been designed and developed intelligently based upon our understanding of how nerves regenerate and will help bridge the gap between hollow conduit and allograft. NeuraGen 3D can really make a difference in terms of how we approach nerve repair and is a significant advancement in the treatment of peripheral nerve repair injuries.”

Harvard, MIT and Mayo Clinic

NeuraGen was, Dr. Archibald explained, developed as a result of the collaboration between Integra and Harvard Medical School. “The outer shell of NeuraGen 3D is an evolution of the NeuraGen nerve guide conduit that was developed in a collaboration with Harvard Medical School in the 1980s.”

“The NeuraGen 3D inner matrix was conceived in collaboration between Integra LifeSciences, the Harvard group and a research team based at MIT, led by Professor Ioannis Yannas. The first significant event during the technical translation of the technology was the Integra team’s identification and patenting of the thermodynamic elements that control the reliable production of the oriented matrix via a controlled freezing process.”

“The second significant event was the successful completion of the pivotal preclinical study at the Mayo Clinic by the team, led by Alexander Shin, M.D. This animal study demonstrated superior functional motor recovery in a rat model as compared with a commercially available empty collagen conduit and also demonstrated no significant difference in the number of axons regenerated with NeuraGen 3D as compared to the nerve autograft. Both these events were crucial in paving the path to commercial production.”

“Orthopedic surgeons have been seeking innovation to solve their clinical challenges in short and mid-gap nerve repair. The introduction of NeuraGen 3D provides surgeons with the next generation of nerve repair technology for the treatment of patients with peripheral nerve injuries. This technology was specifically designed after decades of research on nerve discontinuities. Its unique inner matrix and off-the-shelf capability helps bridge the gap between hollow conduit repair and allograft. NeuraGen 3D enhances a surgeons’ armamentarium and has the potential to make a significant contribution to patient care.”